Grifols is the winner of the 2014 ISPE Facility of the Year Award for Project Execution for their North Fractionation Facility, located in Clayton, North Carolina. The $340 Million project is a 150,000 SF expansion on their existing campus for Human Blood Fractionation.
Product Quality
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Validated a closed process to eliminate contamination risk and reduce clean room space
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Developed a robotic bottle opening system to eliminate potential plasma contact with operators
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Employed automation systems reducing human error and increasing process repeatability
Manufacturing Efficiency
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Expanded site output by 100% to 6MML of plasma
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Lowered labor per liter fractionated by 40%
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Increased process yield between 8 and 15% across fractions produced by leveraging
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Grifols advanced understanding of processing human plasma
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Achieved a 31% reduction in energy per liter with closed process in ambient space
Equipment and Technology
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Built a fully automated processing train reducing cycle times, improving yield, and minimizing human intervention
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Developed in-house process utilizing horizontal thaw vessels, ABO, and precipitation reactors
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Implemented the industry’s first disc-stack centrifuge for fractionation, featuring closed processing, CIP systems operating in ambient conditions
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Achieved a 90% reduction in medical waste generated per liter fractionated
Facility Integration
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Produced a modern, sustainable facility that eliminated harsh cold work environments while achieving excellent functional arrangements resulting in a minimization of material movement
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Contained manufacturing operations on a single level
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Minimized clean room footprint to 12% of gross space
Project Execution
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Fully integrated, co-located project team consisting of both owner and EPCM(V) contractor staff allowing for the concurrent design and construction schedule to work
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Used onsite fabrication shop and super skid approach; saving 4 months and 15% of cost
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Assembled pilot centrifuge installation to develop and debug software
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Leveraged RV/IV commissioning data for use in final qualification package